# K974885: Blackstone Medical Inc. Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Jun 17, 1998 after 169 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
296 later devices descend from it; 10 cite it directly.
0 of 297 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CODMAN Anterior Cervical Plate System: named in the summary without a submission number
- (no number) SYNTHES Cervical Locking Plate System: named in the summary without a submission number
- (no number) SOFAMOR DANEK ORION Anterior Cervical Plate System: named in the summary without a submission number

## Most influential descendants
- K000486: Abc Cervical Plating System (2000), 289 descendants of its own
- K050813: Abc 2 Screw (2005), 145 descendants of its own
- K133475: Struxxure Anterior Cervical Plate and Screws (2013), 132 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K122910: Archon Anterior Cervical Plate Syste, (2012), 101 descendants of its own

## Indications for use
The BLACKSTONE MEDICAL, INC. Anterior Cervical Plate System is to be used for anterior screw fixation of the cervical spine (C2-C7). The indications are as follows: Indications: Degenerative Disc Disease (ddd)* *Back pain of discogenic origin with degeneration of the disc as confirmed by history and radiographic studies. Spondylolisthesis Fracture Spinal Stenosis Deformities (i.e., scoliosis, kyphosis, lordosis) Tumor Pseudoarthrosis Revision of previous failed fusion surgery

Source page: https://510kreport.com/device/K974885
Methodology: https://510kreport.com/methodology